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Amendments

Amendments to a research project which may affect the ongoing ethical and scientific acceptability of the research project or the suitability of the research site must be submitted for review to both the Metro South Health Human Research Ethics Committee (HREC) Office and Metro South Health Research Governance Office.

Research governance requires - Head of Department and Business/Finance Manager approval to support the ongoing conduct of the research project within the Division/Department.

Some requirements for amendments are as follows:

Research project amendments that may affect the ongoingethical acceptability and site acceptability of the research are submitted to the Metro South Health Human Research Ethics Committee (HREC) for review.

Research project amendments that only affect the site acceptability of the research are submitted to the Metro South Health Research Governance Office.

An administrative amendment is defined as changes to the details of research that have no significant implications for participants or for the conduct, management or scientific value of the research project for example:

correction of typographical errors in the protocol or other research project documentation

amended contact details for the sponsor or research project staff

appointment of new or change of support staff contact.

Amendment fees

There is no charge for amendment submitted to the Metro South Health Research Governance Office.

Other than administrative changes all amendments to previously approved pharmaceutically sponsored research protocols that are submitted to the Metro South Health Human Research Ethics Committee (HREC) for review. Please see Research Fees Procedure (PR2017/123) (PDF, 203.26 KB) for more information.

PowerTrials

It is mandatory to maintain the PowerTrials record in the Electronic Medical Record.